A Comparison of Infection Rates Between Two Surgical Sites
Information source: Mayo Clinic
Information obtained from ClinicalTrials.gov on February 07, 2013 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Corneal Toxicity; Ototoxicity; Surgical Site Infection
Phase: N/A
Status: Recruiting
Sponsored by: Mayo Clinic Official(s) and/or principal investigator(s): Jerry Brewer, MD, Principal Investigator, Affiliation: Mayo Clinic
Summary
Does the use of chlorhexidine scrub prior to cutaneous surgery on the face increase the
chances of toxicity to the eyes or ears? In addition, does the us eof chlorhexidine scrub
on the face prior to cutaneous surgery decrease the chances of a post-operative wound
infection?
Clinical Details
Official title: A Comparative Assessment Between Two Surgical Sites of the Rate of Corneal Toxicity and Ototoxicity With the Use of Povidone-iodine Versus Chlorhexidine-alcohol for Facial Lesions Treated With Mohs Micrographic Surgery
Study design: Observational Model: Cohort, Time Perspective: Prospective
Detailed description:
The intent of this proposed prospective observational cohort study is to determine if there
is a difference in the incidence of corneal toxicity and/or ototoxicity in study subjects
undergoing Mohs micrographic surgery (MMS) on the face if a povidone-iodine preparation is
used pre-operatively as compared to a chlorhexidine-alcohol preparation. It has recently
been found that the use of a chlorhexidine-alcohol preparation is superior to the use of a
povidone-iodine preparation in preventing post-operative surgical-site infections (SSI) in
patients undergoing clean-contaminated surgery. However, the use of chlorhexidine on the
face has previously been associated with corneal toxicity and ototoxicity. This study will
help to further define previously reported risks of corneal toxicity and ototoxicity
associated with the use of a chlorhexidine solution on the face.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients undergoing an outpatient cutaneous surgical procedure on the face.
Exclusion Criteria:
- Those who do not consent to participation
- Those undergoing cutaneous surgery for a lesion on the eyelid margin
- Patients with a history of ongoing eye pain
- History of a pre-existing corneal ulcer within 12 months prior to surgery
- History of a perforated tympanic membrane
- Patients with an active infection at the surgical site at the time of surgery.
- If post-operative follow-up is not completed, the study subject will be excluded from
the analysis.
Locations and Contacts
Mayo Clinic in Rochester, Rochester, Minnesota 55905, United States; Recruiting Jerry Brewer, MD, Email: brewer.jerry@mayo.edu
Additional Information
Starting date: January 2011
Last updated: May 24, 2012
|